The Association Between Unprotected Standing, Walking and Wound Healing in Diabetes

Not Applicable

Completed

• Conditions: Diabetic Foot

• Registration Number: NCT02233179
• Lead Sponsor: University of Arizona

Brief Summary

The aim of the study was to explore the association between activities of daily living ( measured using a body-worn sensor) on wound healing in diabetic patients. Since this was an exploratory study, there was no study hypothesis.

Detailed Description

Diabetes patients with active foot ulcers were recruited and monitored for activities of daily living while wearing an offloading device.

Study Timeline

• Study Start: 2009-06
• Primary Completion: 2011-08
• Study Completion: 2012-11
• Study First Submitted: 2014-08-08
• Status Verified: 2014-09
• Study First Submitted QC: 2014-09-03
• Last Update Submitted: 2014-09-03
• Study First Posted: 2014-09-08
• Last Update Posted: 2014-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

• age 18 or older with non-infected, non-ischemic foot ulcers
• active neuropathic foot ulcer

Exclusion Criteria

• major foot amputation
• active Charcot arthropathy
• ankle brachial index of 0.5 or less
• history of substance abuse within 6 months
• inability to walk 20m

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Wound size	12 weeks	Wound size was measured every week for 12 weeks
Daily Physical Activities	12 weeks	Recorded using a body-worn sensor and measured every 4 weeks for 2 days.

Trial Locations

Locations (1)

University Medical Center; 🇺🇸 Tucson, Arizona, United States